Spina Bifida or Spinal Dysraphism Clinical Trial
— QUALI B9Official title:
Knowledge and Follow-up of Vitamin B9 Supplementation Recommendations for Women in the Periconceptional Period to Prevent Neural Tube Closure Defects: a Study Conducted With Health Professionnals and Women Who Have Just Given Birth in Rennes CHU.
| Verified date | April 2023 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU. This study aimes to assess men's and women's knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign. This will allow comparing the results before and after the prevention campaign.
| Status | Completed |
| Enrollment | 1284 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | September 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Questionnaires to women who have just given birth: - Women >= 18 years old, hospitalized in obstretric wards in Rennes CHU - Having given birth within 2 weeks of completing the questionnaire Questionnaires to hospital professionals: - People working at the Rennes CHU - Using a standard email address...@chu-rennes.fr Exclusion Criteria: Questionnaires to women who have just given birth: - Non-French-speaking - Cognitive impairment preventing understanding of the questionnaire and self-reporting - Person under legal protection - Person subject to a measure to safeguard justice - Refusal to participate Questionnaires to university hospital professionals: - Refusal to participate |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Rennes | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. | Proportion of people who were or had a spouse supplemented during her last pregnancy. | the inclusion day | |
| Secondary | To assess the proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period. | Proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period. | the inclusion day | |
| Secondary | To describe the type of B9 vitamin supplementation taken by women before and during pregnancy (alone or in a multivitamin supplement) and the modalities of intake (dosage, frequency, duration before and during pregnancy, etc.) | Dosage, frequency, duration before and during pregnancy, type of supplementation alone or in a multivitamin supplement | the inclusion day | |
| Secondary | To understand how respondents were informed of the value of this supplementation (through their studies, through a health professional, medias, their entourage…) | Source of information about supplementation (through their studies, through a health professional, medias, their entourage…) | the inclusion day | |
| Secondary | To understand why women do not take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness. | Reasons of take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness. | the inclusion day |